Purpose

Participant records on REDCap may need to be deleted or deprecated for various reasons including:

1. Participant withdraws consent and wants their data removed from Brain-CODE

2. Participant leaves the study before data collection begins

3. Duplicate records exist

4. Data upload errors occurred

5. Empty records were created in error

All data entered into REDCap are written to the REDCap database. Only data entered into specific production REDCap projects are copied into Brain-CODE’s federated tables. Queries are written to pull and clean data for dashboards and study metrics.

Deprecation vs. Deletion

Should a record be deprecated or should I request record deletion?

For most cases, deprecating a record is sufficient. Deprecation marks and segregates an erroneous or unneeded record so that it is excluded from post-collection analysis, dashboards, and study metrics.

For cases where there may be an ethical or legal reason to remove a record, IDP members should submit a request for record deletion to an Indoc administrator who will also determine if a security incident review needs to be initiated.

Reasons for Record Deprecation

Deprecation should be used when there is a need to segregate a record so that it is not used in post-collection analysis, dashboards, or study metrics. Data will remain in REDCap and the Brain-CODE federated tables; however, the deprecated participant IDs will not appear in any dashboards or study metrics as deprecated IDs are filtered out in dashboard queries.

How to Deprecate a Record

1. Navigate to the REDCap project that contains the record that requires deprecation

2. Click on Record Status Dashboard in the left hand column and click on the participant ID that requires deprecation to navigate to the Record Home Page

3. Click Choose action for record

4. Click Rename record in the action items dropdown

Open

5. Type in “_deprecated” after the participant ID in the record name box and click Rename record

Open

6. Click Choose action for record and select Assign to Data Access Group from the action items drop down

7. Select Deprecated from the Data Access Group list. If this Data Access Group does not exist, please submit a Help Desk Ticket to contact a REDCap administrator for assistance.

8. Write a Note to File in a text file and upload to the File Repository. Example and template for the Note to File are included below.

Reasons for Record Deletion

Deletion should only be performed when it is unethical or illegal for the data to exist on Brain-CODE. In this case, all data must be removed from all Data Capture Tools, databases, and dashboards including test projects. Deletion in production projects is a permission reserved for Brain-CODE administrators, as this allows for evaluation of potential security incidents. Records that have been deleted from REDCap will not be available for view, extract, or any post-collection analyses.

To determine if deletion is necessary, or to discuss any other concerns about data existing on Brain-CODE, please contact your IDP Team Lead at Indoc, submit a Help Desk Ticket, or email help@braincode.ca.

How to Request Record Delete

1. Identify which participant ID needs to be deleted and where their data exists in REDCap

2. Submit a Deletion Request via email to help@braincode.ca or to your IDP’s Team Lead at Indoc using the template below:

3. Follow any additional instructions given to you by your IDP Lead or OBI.

4. An administrator will record the details of the deletion request, upload a Note to File to the File Repository in the participant’s REDCap project and reply to the Deletion Request email with a confirmation of record deletion.

Training Data Entry Personnel

To ensure that Brain-CODE’s Governance and Securities policies are upheld, please make sure all data entry personnel are trained on:

• the importance of the Subject Enrolment and Informed Consent eCRF

• the difference between deprecating and deleting a record

• how to deprecate and delete a record